Conference Description:

Supplier selection and management is a fundamental issue faced by medical device manufacturers. Suppliers are critical to the performance and safety of your device as well to your business.

Neither the FDA nor your notified body regulates suppliers (with a few exceptions). Instead, they expect you have an effective process that ensures your suppliers perform. The regulators hold you responsible and verify your controls through inspections and audits. Consequently, you need to understand and implement the regulatory requirements for supplier management. You should pass an audit or inspection without any issues.

This course delivers the tools, templates, and methods to help participants implement an effective, efficient, and compliant supplier management program.

This two-day hands-on workshop provides a clear understanding of the underlying principles of supplier management, using exercises to help illustrate the points and solidify understanding. In addition, the course uses FDA Warning Letters to raise issues and help you learn from others. As part of the practical implementation, the course includes supplier evaluation and selection; measuring, monitoring, and re-evaluation; outsourced processes; supplier auditing techniques; and supplier issues in management review.

The workshop uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other important issues and techniques. The course includes information from the ISO 13485:2016 Handbook, FDA’s QSIT, and the MDSAP Audit Model.

Multiple exercises, guidance documents, tools, and templates help you implement an effective program.

Learning Objective:
Upon course completion, participants will:

Understand FDA QSR and ISO 13485:2016 requirements for supplier management
Learn FDA’s inspection techniques from QSIT
Understand supplier management tasks from the MDSAP Audit Model
Understand the FDA’s multi-tier supplier classification system
Understand when suppliers have to register and list with the FDA
Use an analysis matrix and radar chart to compare suppliers
Explain the link between design control and purchasing data
Develop an overall supplier management plan
Understand how to develop and implement supplier controls
Create receiving inspection criteria and apply them as part of supplier controls
Create supplier measurement, monitoring, and re-evaluation processes
Create a system for supplier business risk
Create a system for supplier regulatory risk
Create a risk based system for supplier audits
Develop a supplier audit using the backward tracing process approach


Who Will Benefit:

Quality Managers
Supply Chain Managers
Quality Engineers
Supplier Quality Engineers
Purchasing Professionals
Regulatory Specialists
Production and Process Engineers